NCT00122421

Brief Summary

The goal of this study is to investigate a comprehensive provider-focused intervention to improve the quality of care for diabetic patients in a large primary care practice at Brigham and Women's Hospital. This will be accomplished through pharmacist recommendations provided to primary care providers prior to routine scheduled office visits for diabetic patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Jun 2003

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

February 20, 2012

Status Verified

February 1, 2012

Enrollment Period

6.7 years

First QC Date

July 19, 2005

Last Update Submit

February 17, 2012

Conditions

Diabetes Mellitus

Keywords

diabetesquality of carepharmacist recommendations

Outcome Measures

Primary Outcomes (1)

  • Compliance with process measures at 30 days after the index primary care visit

    aspirin use, ace inhibitor use, a1c measurement

    30 days

Secondary Outcomes (1)

  • Percentage of pharmacist recommendations accepted by primary care providers within 30 days after index visit

    30 days

Study Arms (2)

pharmacist recommendation

ACTIVE COMPARATOR

recommendations based on chart review by pharmacist, given to pcp at time of visit

Behavioral: Pharmacist recommendations to primary care providersOther: pharmacist recommendations

usual care

NO INTERVENTION

usual care

Interventions

Pharmacist recommendations to primary care providersBEHAVIORAL

recommendations based on chart review by pharmacist, given to pcp at time of visit

pharmacist recommendation
pharmacist recommendationsOTHER

recommendations based on chart review by pharmacist, given to pcp at time of visit

pharmacist recommendation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of diabetes
  • Age 18 years or older
  • Identifiable primary care physician (PCP)
  • Attendance at index appointment with PCP

You may not qualify if:

  • No assigned PCP
  • Non-attendance at PCP appointment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Rebecca J Cunningham, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 19, 2005

First Posted

July 22, 2005

Study Start

June 1, 2003

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

February 20, 2012

Record last verified: 2012-02

Locations

US(1)